Type 2 Diabetes MellitusNCT02666807
Effects of Ginger Supplementation on NF-KB in Peripheral Blood Mononuclear Cells in Type 2 Diabetes Mellitus
A study testing Ginger in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences.
Trial summary
This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 2 of diabetes diagnosed for 1 to 10 years
- age 30-60 years
- BMI = 18.5-35 kg/m*m
- treatment with Metformin or Glibenclamide
Who cannot join
- Treatment with insulin
- Weight loss more than 10% in 6 months
- Treatment with TZDs (thiazolidinediones)
- Pregnancy and breast feeding
- Smoking and alcohol consumption
- Multivitamin-mineral and polyphenols and omega-3 and 6 supplementation in the last 3 months and during study
Show all 13Show fewer
- Ginger supplementation and herbal medicines
- Anticoagulation consumption such as heparin and warfarin
- NSAIDs such as diclofenac and salicylate drugs such as aspirin, corticosteroids such as prednisone consumption during 1 month ago and during the study
- Infectious and inflammatory diseases such as rheumatoid arthritis
- Impaired hepatic, renal and gastrointestinal function
- Cancer
- Currently suffering from acute illness that needs medical treatment
About this study
Official title: Effects of Oral Ginger Supplementation on NF-KB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) in Peripheral Blood Mononuclear Cells (PBMC) and Glycemic and Lipid Profiles in Patients With Type 2 Diabetes Mellitus
This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo.
Read the detailed description
ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin resistance as a result of NF-KB reduction in diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Ginger, placebo
- Keywords
- NF-κB, Ginger
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDietary supplement
Also called Zingiber officinale Roscoe
Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
placeboDietary supplement
Also called wheat flour capsules
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Experimental | Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks Receives: Dietary Supplement: Ginger |
| Placebo | Placebo comparator | Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in NF-KB at 10 weeks
Measured: Baseline and 10 weeks
Secondary outcomes (7)
Change from Baseline in FBS (mg/dl) at 10 weeks
FBS (Fasting Blood sugar) (mg/dl)
Measured: Baseline and 10 weeks
Change from Baseline in HDL-C (mg/dl) at 10 weeks
HDL-C (High Density Lipoprotein) (mg/dl)
Measured: Baseline and 10 weeks
Change from Baseline in LDL-C (mg/dl) at 10 weeks
LDL-C (Low Density Lipoprotein) (mg/dl)
Measured: Baseline and 10 weeks
Change from Baseline in Total-C (mg/dl) at 10 weeks
Total-C (Total Cholesterol) (mg/dl)
Measured: Baseline and 10 weeks
Change from Baseline in TG (mg/dl) at 10 weeks
TG (Triacylglycerol) (mg/dl)
Measured: Baseline and 10 weeks
Change from Baseline in Hb A1C at 10 weeks
Hb A1C (Glycated hemoglobin)
Measured: Baseline and 10 weeks
Change from Baseline in insulin (µlU/ml) at 10 weeks
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niaz Mohammadzadeh Honarvar, Tehran University of Medical Sciences
- Investigators
- Ahmad Saedisomeolia, Prof.assoc, Study director, Tehran University of Medical SciencesMotahare Makhdoomiarzati, Msc student, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666807
- Sponsor's protocol ID
- TehranUMS
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jung HW, Yoon CH, Park KM, Han HS, Park YK. Hexane fraction of Zingiberis Rhizoma Crudus extract inhibits the production of nitric oxide and proinflammatory cytokines in LPS-stimulated BV2 microglial cells via the NF-kappaB pathway. Food Chem Toxicol. 2009 Jun;47(6):1190-7. doi: 10.1016/j.fct.2009.02.012. Epub 2009 Feb 20.
PubMed 19233241Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.
PubMed 17950516Li XH, McGrath KC, Tran VH, Li YM, Duke CC, Roufogalis BD, Heather AK. Attenuation of Proinflammatory Responses by S-[6]-Gingerol via Inhibition of ROS/NF-Kappa B/COX2 Activation in HuH7 Cells. Evid Based Complement Alternat Med. 2013;2013:146142. doi: 10.1155/2013/146142. Epub 2013 Jun 16.
PubMed 23843863Ogawa Y, Yamaguchi K, Tanaka T, Morozumi M, Kitagawa R. [Evaluation of the enzymatic method using oxalate oxidase for urinary oxalate assay]. Hinyokika Kiyo. 1987 Dec;33(12):1951-4. Japanese.
PubMed 3448918
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Ginger Supplementation on NF-KB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) in Peripheral Blood Mononuclear Cells (PBMC) and Glycemic and Lipid Profiles in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02666807
- Acronym / sponsor ID
- TehranUMS
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- NF-κB, Ginger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo.
Detailed description
ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin resistance as a result of NF-KB reduction in diabetes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Dietary Supplement: GingerGinger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placeboPlacebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- type 2 of diabetes diagnosed for 1 to 10 years
- age 30-60 years
- BMI = 18.5-35 kg/m*m
- treatment with Metformin or Glibenclamide
Key exclusion criteria (13 listed)
- Treatment with insulin
- Weight loss more than 10% in 6 months
- Treatment with TZDs (thiazolidinediones)
- Pregnancy and breast feeding
- Smoking and alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerAlso: Zingiber officinale RoscoeGinger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks | Dietary supplement | Ginger |
| placeboAlso: wheat flour capsulesPlacebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in NF-KB at 10 weeks
Time frame: Baseline and 10 weeks
7 secondary outcomes
Change from Baseline in FBS (mg/dl) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in HDL-C (mg/dl) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in LDL-C (mg/dl) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in Total-C (mg/dl) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in TG (mg/dl) at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in Hb A1C at 10 weeks
Time frame: Baseline and 10 weeks
Change from Baseline in insulin (µlU/ml) at 10 weeks
Time frame: Baseline and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Results publication: PubMed 19233241Jung HW, Yoon CH, Park KM, Han HS, Park YK. Hexane fraction of Zingiberis Rhizoma Crudus extract inhibits the production of nitric oxide and proinflammatory cytokines in LPS-stimulated BV2 microglial cells via the NF-kappaB pathway. Food Chem Toxicol. 2009 Jun;47(6):1190-7. doi: 10.1016/j.fct.2009.02.012. Epub 2009 Feb 20.
- Results publication: PubMed 17950516Ali BH, Blunden G, Tanira MO, Nemmar A. Some phytochemical, pharmacological and toxicological properties of ginger (Zingiber officinale Roscoe): a review of recent research. Food Chem Toxicol. 2008 Feb;46(2):409-20. doi: 10.1016/j.fct.2007.09.085. Epub 2007 Sep 18.
- Results publication: PubMed 23843863Li XH, McGrath KC, Tran VH, Li YM, Duke CC, Roufogalis BD, Heather AK. Attenuation of Proinflammatory Responses by S-[6]-Gingerol via Inhibition of ROS/NF-Kappa B/COX2 Activation in HuH7 Cells. Evid Based Complement Alternat Med. 2013;2013:146142. doi: 10.1155/2013/146142. Epub 2013 Jun 16.
- Results publication: PubMed 3448918Ogawa Y, Yamaguchi K, Tanaka T, Morozumi M, Kitagawa R. [Evaluation of the enzymatic method using oxalate oxidase for urinary oxalate assay]. Hinyokika Kiyo. 1987 Dec;33(12):1951-4. Japanese.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Saedisomeolia, Prof.assoc study director
Tehran University of Medical Sciences
Motahare Makhdoomiarzati, Msc student principal investigator
Tehran University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Ginger in people with Type 2 Diabetes Mellitus, run by Tehran University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in NF-KB at 10 weeks (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666807, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.